CDR Template - Table of Studies Instructions for Manufacturers Carefully review the instructions below before populating the table of studies.

Studies to include in each section of the table: 1. Contact CADTH for guidance if the drug for the indication(s) to be reviewed, or a component active ingredient, has been available for more than 10 years in Canada or internationally. Please note that this does not apply to submissions for subsequent entry biologics (SEBs). For all SEB submissions, only include studies involving the SEB in the completed table of studies (i.e., do not include studies involving only the reference product).

2. Studies are to be listed in the table irrespective of their publication status (i.e., both published and unpublished studies must be listed).

3. The table of studies must be divided into the following three sections:  List of Studies Provided in the Submission (for the Indication[s] to be Reviewed) must include: . All pivotal studies for the indication(s) to be reviewed. . Any additional interventional phase 2, 3 or phase 4 studies. . Any institution- or investigator-initiated randomized controlled trials (i.e., clinical trials not initiated by a commercial sponsor).  List of Studies Not Provided in the Submission (for All Indications) must include: . Any pivotal randomized controlled trials for all Health Canada-approved indications other than the indication(s) to be reviewed.  List of All Ongoing Studies (for the Indication[s] to be Reviewed) must include: . Any ongoing randomized controlled trials for the indication(s) to be reviewed. . Any ongoing extension phase studies for the indication(s) to be reviewed.

Completing the sections of the table: 1. Study ID(s)  Provide the combination of numbers and/or letters used to identify the study.  If the study has multiple identifiers, please list the most commonly used one first.

2. Sponsor:  Please provide the complete name of the study sponsor.

3. Description:  Provide the title of the study.  Using the sub-headings provided in the template, briefly describe the study design (e.g., duration, randomized, blinded, etc.), number of patients, intervention and comparators, key outcomes, and the patient population.

4. Phase:  Indicate if study is in Phase 2, 3, or 4 (do not include Phase 1 studies in the table unless they are considered pivotal). 5. Abstracts, Publications and Errata  Using the Citing Medicine format, provide complete citations for all publications, abstracts, and errata for each listed study.

6. Location in Submission  Only complete this column for the first section of the table (i.e., List of Studies Provided in the Submission).  Using the checkboxes, indicate where the data for the study is located in the submission (check all that apply) . Module 2.7.3 of the Common Technical Document (☒ for present; ☐ for absent) . Module 2.7.4 of the Common Technical Document (☒ for present; ☐ for absent) . Articles folder (☒ for present; ☐ for absent) . Clinical Study Report (if provided in the Submission) (☒ Yes; ☐ No)

7. PDF  Only complete this column for the first section of the table (i.e., List of Studies Provided in the Submission).  When available, insert an embedded PDF copy of the abstract or publication into the table.

8. All abbreviations used in the table are to be listed in alphabetical order below the table.

Filing the Completed Table: Save the completed table as a Microsoft Word Document and include it in the Category 1 requirements submission package.

If you have any questions regarding the completion of this table, please contact [email protected] with the complete details of your question(s). Table of Studies for [insert Brand Name of drug] Location Study Start & End Abstracts, Publications in Sponsor Description Phase PDF ID(s) Date and Errata Submissi on List of All Studies Provided in the Submission (For the Indication[s] under Review) Title: 2, 3, or 4 Start: 1. Citation #1 ☐ CTD Study Design: double blind, MM/YYYY 2.7.3 placebo-controlled, ☐ CTD multicentre RCT End: MM/YYYY 2.7.4 2. Citation #2 Randomized N: Total sample ☐ Articles size *all citations must use folder Population: Brief description the Citing Medicine ☐ CSR Intervention(s): Drug under format Provided review, dosage, administration frequency Comparator(s): Comparator(s) dosage, administration frequency Outcomes: Primary and key secondary endpoints List of Studies Not Provided in the Submission (for All Indications) Title: 2, 3 or 4 Start: 1. Citation #1 N/A N/A Study Design: double blind, MM/YYYY placebo-controlled, multicentre RCT End: MM/YYYY 2. Citation #2 Randomized N: Total sample size Population: Brief description Intervention(s): Drug under review, dosage, administration frequency Comparator(s): Comparator(s) dosage, administration frequency Outcomes: Primary and key secondary endpoints List of All Ongoing Studies (For the Indication[s] under Review) Provide a brief description 2, 3 or 4 Start: N/A N/A MM/YYYY Anticipated end: MM/YYYY Abbreviations: (Provide a list of all abbreviations used in the table) CSR=Clinical Study Report; CTD=Common Technical Document; N=total number of patients; N/A=not applicable; RCT=randomized controlled trial Example of a Completed Table of Studies Entry for Drug A Location Study Start &End Abstracts, Publications in Sponsor Description Phase PDF ID(s) Date and Errata Submissi on List of All Studies Provided in the Submission (For the Indication[s] under Review) AB1234 Bones Title: Efficacy of Drug A in 3 Start: 02/2005 1. Jones, F. Drug A: ☒ CTD 5 Manufacture reducing hip fractures in efficacy results from a 2.7.3 r Inc. adults with osteoporosis. End: 06/2017 phase 3 clinical trial. ☒ CTD Study Design: A two-year Journal Name. 2008 Jan; 2.7.4 62(1):112-6 randomized, double blind, ☒ placebo-controlled, multi- Articles 2. Jones, F. Drug A: centre trial section interim results from a ☒ Randomized N: 552 Phase 2/3 clinical trials CSR Population: adults with [abstract]. Association for Provided osteoporosis Research in Osteoporosis Intervention(s): Drug A: 50 Annual Meeting. 2005 mg orally BID April 25-26; New Orleans. Abstract No. 23. Comparator(s): Comparator 1: 50 mg orally BID Outcomes: Hip fractures, bone mineral density Abbreviations: (Provide a list of all abbreviations used in the table) BID=twice daily; CSR=Clinical Study Report; CTD=Common Technical Document; N=total number of patients; N/A=not applicable; RCT=randomized controlled trial